Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000152426

Enrollment

Registered

2007-03-01

Start date

1998-10-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Low systemic blood flow in the early hours after birth is a common problem in very preterm babies. It is associated with a range of adverse outcomes. This trial aims to test the efficacy of the two commonly used inotropes in preterm babies. Inotropes are drugs that improve the pumping performance of the heart.

Interventions

Dopamine vs dobutamine by continuous intravenous infusion. Two dosage steps for each drug. 10 and 20 micrograms/kg/min. If Doppler ultrasound measures of systemic blood flow increased on 10 microgram/kg/min then they remain on that dose. If no increase in systemic blood flow at 10 micrograms/kg/min then they increased to 20 micrograms/kg/min. If they increased systemic blood flow on 20 micrograms/kg/min then they remain on that dose. If no increase in systemic blood flow at 20 micrograms/kg/min then crossover immediately to the other drug with no washout period and the dose escalation process repeated with the other syringe (drug). The infusion was maintained until 24 hours of age then weaned at the discretion of the treating medical staff.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 30 Weeks

Healthy volunteers

Inclusion criteria

Born before 30 weeks and low systemic blood flow.

Exclusion criteria

Major intraventricular haemorrhage before intervention commences, not expected to survive.

Outcome results